POTASSIUM CHLORIDE tablet, extended release
Potassium Chloride by
Drug Labeling and Warnings
Potassium Chloride by is a Prescription medication manufactured, distributed, or labeled by Vensun Pharmaceuticals, Inc., Pharmaceutics International, Inc. (Pii), Pharmaceuticals International, Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP safely and effectively. See full prescribing information for POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP
POTASSIUM CHLORIDE EXTENDED-RELEASE Tablets, USP, for oral use
Initial U.S. Approval: 1948INDICATIONS AND USAGE
Potassium chloride extended-release tablets, USP are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)
DOSAGE AND ADMINISTRATION
- Monitor serum potassium and adjust dosages accordingly (2.1)
- If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1)
- Take with meals and with a glass of water or other liquid. Swallow tablets whole without crushing, chewing or sucking. (2.1)
- Treatment of hypokalemia: Doses range from 40-100 mEq/day in divided doses. Limit doses to 40 mEq per dose. (2.2)
- Prevention of hypokalemia: Typical dose is 20 mEq per day. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)
CONTRAINDICATIONS
- Concomitant use with triamterene and amiloride (4)
WARNINGS AND PRECAUTIONS
- Gastrointestinal Irritation: Take with meals (5.1)
ADVERSE REACTIONS
- The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutics International, Inc. at 1-877-276-5814 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2018
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Administration and Monitoring
2.2 Dosing
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Gastrointestinal Adverse Reactions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Triamterene or amiloride
7.2 Renin-angiotensin-aldosterone Inhibitors
7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Cirrhotics
8.7 Renal Impairment
10 OVERDOSAGE
10.1 Symptoms
10.2 Treatment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
- * Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
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2 DOSAGE AND ADMINISTRATION
2.1 Administration and Monitoring
If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation.
Monitoring
Monitor serum potassium and adjust dosages accordingly. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.
The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate.
Administration
Take potassium chloride extended-release tablets, USP with meals and with a glass of water or other liquid. Do not take potassium chloride extended-release tablets, USP on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions (5.1)].
Swallow tablets whole without crushing, chewing or sucking.
2.2 Dosing
Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose.
Treatment of Hypokalemia: Typical dose range is 40-100 mEq per day.
Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
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5 WARNINGS AND PRECAUTIONS
5.1 Gastrointestinal Adverse Reactions
Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders.
If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets, USP and consider possibility of ulceration, obstruction or perforation.
Potassium chloride extended-release tablets, USP should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration (2.1)].
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6 ADVERSE REACTIONS
The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.
There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation.
Skin rash has been reported rarely.
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7 DRUG INTERACTIONS
7.1 Triamterene or amiloride
Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4)].
7.2 Renin-angiotensin-aldosterone Inhibitors
Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients on concomitant RAAS inhibitors.
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8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no human data related to use of potassium chloride extended-release tablets, USP during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.
The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
8.2 Lactation
Risk Summary
The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.
8.5 Geriatric Use
Clinical studies of potassium chloride extended-release tablets, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
8.6 Cirrhotics
Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see Clinical Pharmacology (12.3)].
8.7 Renal Impairment
Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia [see Warnings and Precautions (5.2)]. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.2, 7.3)] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically.
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10 OVERDOSAGE
10.1 Symptoms
The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications and Warnings].
It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L).
10.2 Treatment
Treatment measures for hyperkalemia include the following:
- Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties.
- Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL.
- Correction of acidosis, if present, with intravenous sodium bicarbonate.
- Use of exchange resins, hemodialysis or peritoneal dialysis.
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.
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11 DESCRIPTION
Potassium chloride extended-release tablets, USP are a solid oral dosage form containing 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet.
Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.
Inactive Ingredients: Carnauba wax, magnesium stearate, talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. 600 mg tablets also contain FD&C blue #2/indigo carmine aluminum lake and FD&C blue #1/brilliant blue FCF aluminum lake.750 mg tablets also contain D&C yellow no.10 aluminum lake and FD&C yellow no.6/sunset yellow FCF aluminum lake.
“USP Dissolution Test Pending.”
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12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.
12.3 Pharmacokinetics
The potassium chloride in potassium chloride extended-release tablets, USP is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release tablets, USP is compared to that of a true solution the extent of absorption is similar.
The extended-release properties of potassium chloride extended-release tablets, USP are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the potassium chloride extended-release tablets, USP dose as compared to the solution.
Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release tablets, USP, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of potassium chloride extended-release tablets, USP cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion.
- 13 NONCLINICAL TOXICOLOGY
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16 HOW SUPPLIED/STORAGE AND HANDLING
Potassium Chloride Extended-Release Tablets, USP, 8 mEq
Potassium chloride extended-release tablets, USP, 8 mEq, are film-coated (blue, debossed with “P” and “271”), round tablets containing 600 mg potassium chloride (equivalent to 8 mEq) available as follows:
NDC: 42543-133-01: Bottles of 100 tablets
NDC: 42543-133-05: Bottles of 500 tablets
Potassium Chloride Extended-Release Tablets, USP, 10 mEq
Potassium chloride extended-release tablets, USP 10 mEq, are film-coated (yellow, debossed with “P” and “272”), round tablets containing 750 mg potassium chloride (equivalent to 10 mEq) available as follows:
NDC: 42543-134-01: Bottles of 100 tablets
NDC: 42543-134-05: Bottles of 500 tablets
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.]. Protect from light and moisture.
Dispense in a tight container with a child-resistant closure.
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17. PATIENT COUNSELING INFORMATION
- Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool.
- Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed.
Rx Only
Manufactured for:
Vensun Pharmaceuticals, Inc.
Yardley, PA 19067Manufactured by:
Pharmaceutics International, Inc.
Hunt Valley, MD 21031Rev. 00, August 2018
- Principal Display Panel - 8 mEq 100 Tablets Label
- Principal Display Panel - 8 mEq 500 Tablets Label
- Principal Display Panel - 10 mEq 100 Tablets Label
- Principal Display Panel - 10 mEq 500 Tablets Label
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INGREDIENTS AND APPEARANCE
POTASSIUM CHLORIDE
potassium chloride tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 42543-133 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) Potassium Chloride 600 mg Inactive Ingredients Ingredient Name Strength Carnauba Wax (UNII: R12CBM0EIZ) Talc (UNII: 7SEV7J4R1U) Magnesium Stearate (UNII: 70097M6I30) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Blue No. 1 (UNII: H3R47K3TBD) FD&C Blue No. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue (Blue) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code P;271 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 42543-133-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/22/2019 2 NDC: 42543-133-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206881 01/22/2019 POTASSIUM CHLORIDE
potassium chloride tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 42543-134 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) Potassium Chloride 750 mg Inactive Ingredients Ingredient Name Strength Carnauba Wax (UNII: R12CBM0EIZ) Talc (UNII: 7SEV7J4R1U) Magnesium Stearate (UNII: 70097M6I30) Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Titanium Dioxide (UNII: 15FIX9V2JP) D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Yellow No. 6 (UNII: H77VEI93A8) Product Characteristics Color yellow (Yellow ) Score no score Shape ROUND (ROUND) Size 13mm Flavor Imprint Code P;272 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 42543-134-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/22/2019 2 NDC: 42543-134-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206881 01/22/2019 Labeler - Vensun Pharmaceuticals, Inc. (078310501) Registrant - Pharmaceutics International, Inc. (Pii) (878265586) Establishment Name Address ID/FEI Business Operations Pharmaceuticals International, Inc 878265586 MANUFACTURE(42543-133, 42543-134) , ANALYSIS(42543-133, 42543-134)
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